LUAN 2.5% Gel

Зміст інструкції

1. LUAN 2,5% gel
   1. What Luan is and what it is used for
   2. What you need to know before you use Luan
   3. How to use Luan
   4. Possible side effects
   5. How to store Luan
   6. Contents of the pack and other information
2. LUAN 1% gel
   1. What Luan is and what it is used for
   2. What you need to know before using Luan
   3. How to use Luan
   4. Possible side effects
   5. How to store Luan
   6. Contents of the pack and other information

LUAN 2,5% gel

Lidocaine hydrochloride

Read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your doctor or pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What LUAN is and what it is used for
• 2. What you need to know before using LUAN
• 3. How to use LUAN
• 4. Possible side effects
• 5. How to store LUAN
• 6. Contents of the pack and other information

1. What Luan is and what it is used for

Luan contains the active ingredient lidocaine hydrochloride which belongs to a group of
medicines called local anesthetics that block the sensation of pain in the area where
they are applied.
Luan is indicated to facilitate endourethral maneuvers, such as:
the introduction of catheters into the urethra; bladder dilations and examinations (cystoscopy) for
exploratory and therapeutic purposes.

2. What you need to know before you use Luan

Do not use Luan if:

• you are allergic to lidocaine hydrochloride, to similar substances (local anesthetics of the amide type) or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautionsTalk to your doctor or pharmacist before using Luan. This medicine should be used in the smallest amount necessary to achieve the desired effect and application for long periods of time should be avoided, as allergic reactions (sensitization phenomena) may occur. In this case, it is recommended to stop treatment and inform the doctor who will prescribe suitable therapy.

This medicine should be used with caution if in the area of application:

• there are severely damaged or inflamed mucous membranes;
• there is a severe infection (sepsis) of the mucous membranes. In these cases, in fact, an excessive amount of lidocaine may pass into the blood and cause serious disorders of the nervous system (CNS), heart and circulation (cardiovascular system), especially in children, the elderly and debilitated people (see section “Possible side effects”).

Children
This medicine should be used with caution in children, especially if there are lesions, inflammation or severe infections of the mucous membranes at the site of
application.

Other medicines and Luan
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine..
Use Luan with caution if you are taking the following medicines because they can increase the
effects of lidocaine:

• propranolol, used for the treatment of high blood pressure;
• cimetidine, used to treat stomach disorders.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding with breast milk, ask your doctor or pharmacist for advice before using this medicine.

Driving and operating machinery
This medicine does not alter the ability to drive vehicles or operate machinery.

Luan contains para-hydroxybenzoates and sodium benzoate
This medicine contains para-hydroxybenzoates which may cause allergic reactions
(even delayed).
Luan contains sodium benzoate, which is slightly irritating to the skin, eyes and mucous membranes.

3. How to use Luan

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Luan will be administered directly into the urethra, by squeezing the tube and applying a urethral clamp for 10
minutes, after which the desired endourethral maneuvers can be performed. The contents of the tube are sufficient to completely fill the urethra.
To facilitate the introduction of the medicine and avoid pain caused by direct contact with the metallic parts of the tube, the plastic applicator contained in the package may be screwed onto the tube at the time of use.
This medicine should be used with caution if you have damaged mucous membranes or a severe
infection (sepsis) (See section “Warnings and precautions”).

If you use more Luan than you should
If you are administered an excessive amount of this medicine, the following symptoms may occur:

• tremors and convulsions followed by depression (neuroexcitatory manifestations), severe breathing problems (respiratory failure) and a deep state of unconsciousness (coma);
• problems with the heart and circulation (cardiovascular alterations) with a decrease in blood pressure (hypotension) and slowing of the heartbeat (bradycardia). The doctor will determine the most appropriate therapy for you, based on the severity of the symptoms. If you are worried that a higher than recommended dose of medicine may have been used, inform your doctor immediately.

4. Possible side effects

Like all medicines, Luan can cause side effects, although not everybody gets them.
Side effects that may occur are listed below:

• allergic reactions (hypersensitivity) at the application site, characterised by pain, burning and itching;
• severe allergic reaction (anaphylactic shock);

When the medicine is applied to irritated or damaged skin, to large areas of the body, at high doses
or in the presence of fever, the risk of side effects and toxic effects affecting the whole body (systemic)
increases. (See section “Warnings and precautions”).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your doctor or
pharmacist. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Luan

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Luan contains

• The active ingredient is lidocaine hydrochloride. 100 g of gel contains 2.5 g of lidocaine hydrochloride.
• The other ingredients are: sodium carboxymethylcellulose, glycerol, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium benzoate, purified water.

Description of the appearance of Luan and contents of the pack
Pack containing an aluminum tube with a screw cap containing 15 g of gel with an applicator in
plastic.

Marketing Authorisation Holder and Manufacturer

• L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., Strada Statale 67 - Località Granatieri - Scandicci (Firenze)

LUAN 1% gel

Lidocaine hydrochloride

Read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor has told you to do.
Keep this leaflet. You may need to read it again.
If you want more information or advice, ask your doctor or pharmacist.
If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your doctor or pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Luan is and what it is used for
• 2. What you need to know before using Luan
• 3. How to use Luan
• 4. Possible side effects
• 5. How to store Luan
• 6. Contents of the pack and other information

1. What Luan is and what it is used for

Luan contains the active substance lidocaine hydrochloride, which belongs to a group of
medicines called local anesthetics that block the sensation of pain in the area where
they are applied.
Luan is indicated to facilitate the introduction of tubes for anesthesia and in the esophagus (esophagoscopic intubations) and for the insertion of probes into the pharynx, trachea, bronchi or
rectum (pharyngoscopies, tracheo-bronchoscopies, gastroscopies and rectoscopies) and in all endoscopic indications for exploratory and therapeutic purposes.

2. What you need to know before using Luan

Do not use Luan if:

• you are allergic to lidocaine hydrochloride, to similar substances (local anesthetic agents of the amide type) or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautionsConsult your doctor or pharmacist before using Luan. The medicine should be used in the minimum quantity necessary to achieve the desired effect and application for long periods of time should be avoided, as allergic reactions (sensitization phenomena) may occur. In this case, it is recommended to discontinue treatment and inform the doctor who will prescribe a suitable therapy.

The medicine should be used with caution if in the application area:

• there are severely damaged or inflamed mucous membranes;
• there is a severe infection (sepsis) of the mucous membranes. In these cases, in fact, an excessive amount of lidocaine may pass into the blood and cause serious disorders of the nervous system (CNS), heart and circulation (cardiovascular system), especially in children, the elderly and debilitated people (see section “Possible side effects”).

Children
This medicine should be used with caution in children, especially if there are damages, inflammation or severe infections of the mucous membranes at the application site.

Other medicines and Luan
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine..
Use Luan with caution if you are taking the following medicines because they can increase the
effects of lidocaine:

• propranolol, used for the treatment of high blood pressure;
• cimetidine, used to treat stomach disorders.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.

Driving and operating machinery
This medicine does not impair the ability to drive vehicles or operate machinery.

Luan contains para-hydroxybenzoates and sodium benzoate
This medicine contains para-hydroxybenzoates which may cause allergic reactions
(even delayed).
Luan contains sodium benzoate, which is slightly irritating to the skin, eyes and mucous membranes.

3. How to use Luan

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Luan will be applied directly to the device, before starting the surgical procedure.
This medicine must be used with caution if you have damaged mucous membranes or a severe
infection (sepsis), in children, in the elderly and in severely ill patients (See the
section “Warnings and precautions”).

If you use more Luan than you should
If you are given an excessive amount of this medicine, the following symptoms may occur:

• tremors and convulsions followed by depression (neuroexcitatory manifestations), severe breathing problems (respiratory failure) and a deep state of unconsciousness (coma);
• problems with the heart and circulation (cardiovascular alterations) with lowering of blood pressure (hypotension) and slowing of the heartbeat (bradycardia). The doctor will determine the most appropriate therapy for you, based on the severity of the symptoms. If you are concerned that a dose of medicine higher than necessary may have been used, inform your doctor immediately.

4. Possible side effects

Like all medicines, Luan can cause side effects, although not everybody gets them.
Side effects that may occur are listed below:

• allergic reactions (hypersensitivity) at the application site, characterized by pain, burning and itching;
• severe allergic reaction (anaphylactic shock);

When the medicine is applied to irritated or damaged skin, on large areas of the body, at high
doses or in the presence of fever, the risk of undesirable and toxic effects affecting the whole
body (systemic) increases. (See section “Warnings and precautions”).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can
help to provide more information on the safety of this medicine.

5. How to store Luan

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Luan contains

• The active ingredient is lidocaine hydrochloride. 100 g of gel contains 1 g of lidocaine hydrochloride.
• The other ingredients are: sodium carboxymethylcellulose, glycerol, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium benzoate, purified water.

Description of the appearance of Luan and contents of the pack
Pack containing an aluminium tube with a screw cap containing 100 g of gel.

Marketing Authorisation Holder and Manufacturer

• L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., Strada Statale 67 - Località Granatieri - Scandicci (Firenze)